• 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

• 2020-10-28 02:13:28

With Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia.

• 2020-05-12 07:39:23

Health Sciences Authority (HSA) ensure the availability of respiratory devices for COVID – 19 patients. HSA placed flexible regulations such as allowing the use of emergency ventilators, clarifying the applicable change notification category that will not require approval and demonstrating the means for adding new model of respiratory devices.

• 2020-04-14 02:41:07

Qualtech will update you on the new expedite registration channels in China, Singapore, Malaysia, and Indonesia in the context of the COVID-19. While also introducing the existing regular fast tracks for urgently needed medical devices.

• 2020-03-18 10:32:08

The ASEAN Common Submission Dossier Template (CSDT) makes it significantly easier to penetrate the ASEAN markets collectively. Therefore, do not miss the chance to learn about the benefits of the CSDT and what documentations are required for developing the Common Submission Dossiers.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 2020-05-06 09:41:29

The OMETA Seminar is back in 2019, to give those interested the tools to evolve and accelerate their business.

• 2020-02-12 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.

• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,